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3 Weeks away from FDA RedI Conference: Focus on CGMPs and FDA Inspections - Register Today!

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)


REdIGMP

 

FDA Small Business Regulatory Education for Industry (REdI) Conference:

“Focus on CGMPs and FDA Inspections” Summer 2015

 

CDER Small Business and Industry Assistance (SBIA) invites you to our first topic specific two day conference. Join us as we “Focus on CGMPs and FDA Inspections”.

 

July 15-16, 2015

The Sheraton Silver Spring Hotel

Silver Spring, MD

 

Conference Webpage                    Registration

 

This conference is FREE

You may attend in person or online

Advance registration is required

 

During these two days we will discuss the following six essential components of GMPs: Quality

Production

Laboratory

Materials

Facilities and Equipment

Packaging and Labeling

 

We will also help you to identify what to expect when being inspected as we talk about:

FDA quality CGMPs

What FDA investigators do on inspection

What happens after an inspection

How to communicate with FDA during and after an inspection

Your right to dispute a finding or raise an issue

 

All presentations will address appropriate regulations and guidances and will allow time for questions and answers. We will end each day with an examination of specific case studies followed by availability of a panel for further questions.

 

We encourage you attend, interact and engage in productive two way communication with our FDA experts from the Office of Policy for Pharmaceutical Quality; Office Of Manufacturing Quality and Office of Process and Facilities.

 

Please honor your registration commitment. If you are registered and are unable to attend please contact cancelation@sbiaevents.com

 

For more information on

CDER SBIA

CDER SBIA Workshops and Webinars

 


 

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

 

 

 

 

Please take our CDER SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation


This email was sent to using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

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